Cleared Traditional

K133602 - ADD-VANTAGE ADDAPTOR

K133602 is an FDA 510(k) clearance for ADD-VANTAGE ADDAPTOR, manufactured by Hospira, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K133602 · Hospira, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
60d
Days
Class 2
Risk

K133602 is an FDA 510(k) clearance for the ADD-VANTAGE ADDAPTOR. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on January 24, 2014 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K133602

510(k) Number K133602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2013
Decision Date January 24, 2014
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 193
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K133602.
MEDSOURCE SELECTABLE IV SET
K140442 · Medsource International, LLC · Apr 2014
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
K140402 · Medsource International, LLC · Apr 2014
E-Z LINK
K133097 · Duoject Medical Systems, Inc. · Mar 2014
DISPOSABLE INFUSION SET
K131646 · Shanghai Jinta Medical Co., Ltd. · Nov 2013
SMARTSITE VIALSHIELD
K132863 · Yukon Medical, LLC · Oct 2013
MP VIAL ADAPTER 13MM
K130179 · Medimop Medical Projects, Ltd. · Aug 2013
K133602 · ADD-VANTAGE ADDAPTOR
Download PDF FDA Summary Hospira, Inc.